Medical Writing Trends in medical writing The 360° approach to authoring risk management plans
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Volume 28, Issue 3 - Trends in medical writing

The 360° approach to authoring risk management plans

Abstract

Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk management plans. Over the past couple of years, medical writers have been contributing extensively in driving the seamless integration of the recent Good Pharmacovigilance Practices guidance version 2.0 into companies’ global pharma - covigilance systems, quality assurance systems, and relevant standard operating procedures. A comprehensive “360°” approach adapted by medical writers ensures efficient authoring of high-quality RMPs.

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References

  1. ema.europa.eu [Internet]. European Medicines Agency, Risk-management plans, c2017 [cited 2017 Mar 28] Available from: https://www.ema.europa.eu/en/humanregulatory/ marketing-authorisation/ pharmacovigilance/risk-management/riskmanagement- plans.
  2. ema.europa.eu [Internet]. European Medicines Agency, Questions and answers on the risk management plan (RMP) summary, c2017 [cited 2017 Mar 30] Available from: https://www.ema.europa. eu/en/documents/other/questionsanswers- risk-management-plan-rmpsummary_ en.pdf.
  3. ema.europa.eu [Internet]. European Medicines Agency, Guideline on good pharmacovigilance practices (GVP) Module X – Additional monitoring, c2013 [cited 2013 Apr 19] Available from: https://www.ema.europa.eu/en/documents /scientific-guideline/guideline-goodpharmacovigilance- practices-module-xadditional- monitoring_en.pdf.
  4. ec.europa.eu [Internet]. European Commission, Summaries of clinical trial results for laypersons , c2017 [cited 2017 Jan 26] Available from: https://ec.europa.eu/ health/sites/health/files/files/eudralex/vol- 10/2017_01_26_summaries_of_ct_results _for_laypersons.pdf.
  5. ema.europa.eu [Internet]. European Medicines Agency, Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure. c2016 [cited 2016 Jun 01]. Available from: https://www.ema.europa. eu/en/documents/regulatory-proceduralguideline/ practical-questions-answerssupport- implementation-variationsguidelines- centralised-procedure_en-0.pdf.

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Articles

Introduction
President's Message
EMWA News
Omics in silico and other trends in biomedical research: Impact on how and what we write
Catching the wave of lifestyle medicine
Artificial intelligence – will we be replaced by robots?
Now more than ever, scientists must speak up for science
When less is more: Medical writers as guardians of curated content
Predatory publishing – what medical communicators need to know
AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing
How to combat medical misinformation with a sound content strategy
Subcontracting: Not for the faint of heart
Lay summaries and writing for patients: Where are we now and where are we going?
Clinical trial disclosure: Perspective from a medical writer for a contract research organisation
The 360° approach to authoring risk management plans
Trends in regulatory writing: A brief overview for aspiring medical writers
The medical writing landscape in China
News from the EMA
Regulatory Matters
Medical Communications and Writing for Patients
In the Bookstores
Getting Your Foot in the Door
Veterinary Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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